Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder

Официальное название

Feasibility of Culturally Adapted, Nurse-Led COPE Intervention on Psychological Wellbeing of Primary Caregivers of Child With Autism Spectrum Disorder (CASD)

Обзор

This study aims to evaluate the feasibility of a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) in Pakistan. The study will use an exploratory sequential mixed-methods design comprising a qualitative needs assessment followed by a pilot randomized controlled feasibility trial. Qualitative interviews will identify caregivers' training needs and inform the cultural adaptation of the COPE intervention. Eligible caregivers will then be randomly assigned to either an intervention group receiving the culturally adapted COPE program in addition to routine care or a control group receiving routine care alone. The intervention consists of four weekly nurse-led sessions focusing on psychoeducation, cognitive restructuring, coping strategies, positive parenting, emotional regulation, and family resilience. Psychological wellbeing will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21) at baseline and one month after the intervention. The study will also evaluate recruitment, retention, intervention adherence, acceptability, and implementation feasibility to inform the design of a future definitive randomized controlled trial.

Подробное описание

Parents and primary caregivers of children with Autism Spectrum Disorder (ASD) frequently experience substantial psychological distress due to the long-term demands of caregiving, including elevated levels of stress, anxiety, and depression. In Pakistan, limited access to structured caregiver support programs, inadequate mental health services, financial constraints, and social stigma further increase caregiver burden. Although previous parent-mediated interventions conducted in Pakistan have demonstrated benefits for child developmental outcomes, few have specifically addressed the psychological wellbeing of caregivers. The Creating Opportunities for Parent Empowerment (COPE) program is an evidence-based, nurse-led psychoeducational intervention designed to improve parental coping, problem-solving, emotional regulation, and confidence through cognitive-behavioral strategies and structured education. This study seeks to culturally adapt the COPE intervention to ensure its relevance and acceptability within the Pakistani context.

The study will employ an exploratory sequential mixed-methods design. In the first phase, qualitative semi-structured interviews will be conducted with primary caregivers of children with ASD to identify their educational and psychosocial support needs. Findings from the thematic analysis will be used to culturally adapt the COPE intervention. In the second phase, a pilot randomized controlled feasibility trial will be conducted in which eligible caregivers will be randomly assigned to either an intervention group receiving the culturally adapted nurse-led COPE program in addition to routine hospital care or a control group receiving routine hospital care alone. The intervention will comprise four weekly sessions of approximately 45 minutes each, covering understanding ASD, cognitive restructuring, coping strategies, positive parenting, emotional support, and long-term family resilience.

Baseline and one-month follow-up assessments will be conducted using the Depression Anxiety Stress Scale-21 (DASS-21) to evaluate changes in depression, anxiety, and stress. In addition to clinical outcomes, the study will assess feasibility indicators including participant recruitment, retention, intervention adherence, acceptability, and implementation. Qualitative data will be analyzed using Braun and Clarke's thematic analysis approach, while quantitative data will be analyzed using IBM SPSS Statistics version 27 with appropriate descriptive and inferential statistical methods. The findings will provide essential evidence regarding the feasibility and acceptability of the culturally adapted nurse-led COPE intervention and will inform the planning of a fully powered randomized controlled trial aimed at improving the psychological wellbeing of caregivers of children with ASD in Pakistan.

Вмешательства

• Поведенческое Culturally Adapted Nurse-Led COPE Intervention
  The intervention is a culturally adapted, nurse-led behavioral and psychoeducational program based on the Creating Opportunities for Parent Empowerment (COPE) framework. It is designed to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) by enhancing coping skills, emotional regulation, problem-solving abilities, and parenting confidence. The intervention comprises four weekly sessions of approximately 45 minutes each and includes education
• Другое Routine Hospital Care
  Participants receive the standard care routinely provided by the hospital for families of children with Autism Spectrum Disorder. No components of the culturally adapted nurse-led COPE intervention are provided during the study period.

Первичные конечные точки

• Change in Depression Score [Срок оценки: Baseline and 1 month after completion of the intervention.]
• Anxiety [Срок оценки: Baseline and 1 month after completion of the intervention.]
• Stress [Срок оценки: Baseline and 1 month after completion of the intervention.]

Критерии участия

Критерии включения

• Male or female primary caregivers aged 18 years or older.
• Primary caregiver of a child with a confirmed diagnosis of Autism Spectrum Disorder (ASD).
• Able to communicate in Urdu.
• Willing and able to provide written informed consent.
• Available to attend all intervention sessions and follow-up assessments.

Критерии исключения

• Caregivers currently participating in another structured psychosocial, behavioral, or parenting intervention.
• Caregivers with a diagnosed severe psychiatric illness or cognitive impairment that would interfere with participation.
• Caregivers unable to communicate effectively in Urdu.
• Caregivers who decline or are unable to provide informed consent.
• Caregivers who are unavailable to complete the intervention or follow-up assessments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Children Hospital Complex and Institute of Child Health — Faisalābad

Публикации

• Rahman A, Divan G, Hamdani SU, Vajaratkar V, Taylor C, Leadbitter K, Aldred C, Minhas A, Cardozo P, Emsley R, Patel V, Green J. Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): a randomised controlled trial. Lancet Psychiatry. 2016 Feb;3(2):128-36. doi: 10.1016/S2215-0366(15)00388-0. Epub 2015 Dec 17. PMID 26704571
• Ronk FR, Korman JR, Hooke GR, Page AC. Assessing clinical significance of treatment outcomes using the DASS-21. Psychol Assess. 2013 Dec;25(4):1103-10. doi: 10.1037/a0033100. Epub 2013 Jun 3. PMID 23730826
• Alibekova R, Kai Chan C, Crape B, Kadyrzhanuly K, Gusmanov A, An S, Bulekbayeva S, Akhmetzhanova Z, Ainabekova A, Yerubayev Z, Yessimkulova F, Bekisheva A, Ospanova Z, Rakhimova M. Stress, anxiety and depression in parents of children with autism spectrum disorders in Kazakhstan: prevalence and associated factors. Glob Ment Health (Camb). 2022 Oct 11;9:472-482. doi: 10.1017/gmh.2022.51. eCollectio PMID 36618742
• Zeidan J, Fombonne E, Scorah J, Ibrahim A, Durkin MS, Saxena S, Yusuf A, Shih A, Elsabbagh M. Global prevalence of autism: A systematic review update. Autism Res. 2022 May;15(5):778-790. doi: 10.1002/aur.2696. Epub 2022 Mar 3. PMID 35238171
• Batool SS, Khurshid S. Factors Associated with Stress Among Parents of Children with Autism. J Coll Physicians Surg Pak. 2015 Oct;25(10):752-6. doi: 10.2015/JCPSP.752756. PMID 26454393
• Alghamdi K, Alahmadi S, Sayedahmad A, Mosleh H. Psychological Well-Being of Mothers of Children With Autism in Saudi Arabia. Cureus. 2022 Mar 18;14(3):e23284. doi: 10.7759/cureus.23284. eCollection 2022 Mar. PMID 35449665

Идентификаторы

NCT: NCT07722949 · KMU/DIR/CTU/2026/07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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